Letter to the FDA urging
an investigation of Medtronic defibrillator
recall (HRG Publication #1826)
October 16, 2007
Andrew von Eschenbach, MD, Commissioner
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. von Eschenbach:
Important live-saving facts seem to have
been overlooked intentionally by both the
FDA and Medtronic while the two were busy
congratulating one another for doing a better
job detecting and recalling the Medtronic
Sprint Fidelis defibrillator lead than Guidant
did in its product recall several years ago.
I urge you to conduct an immediate investigation
concerning the following:
1. The total number of reports of injury
associated with the Fidelis lead had climbed
to 599 by Jan. 10 2007, including 204 cases
in which patients received "inappropriate
shocks." (See Table and Figures 1 and
2 below.) The number of injury reports for
the first two months of 2007 was 152, compared
with 27 reports for the first two months
of 2006. Some of this reflects the fact that
the longer the defibrillator is implanted,
the greater likelihood there is of a fracture,
inappropriate shock or other medical problem
with the lead.
Why did the FDA, aware of
the rapidly mounting number of injury reports,
not force the company to recall defibrillators
not yet implanted in the early part of this
year? It is likely that the 1,030 injuries
reported to the FDA after Jan. 10 included
many patients with defibrillators implanted
after this date. Had the recall and further
implantations stopped then -- instead
of nine months later (this week) -- many
patients would have been spared the injuries
and anxiety that occurred with these recent
implantations.
Medtronic had been warned about the injuries.
Dr. Robert Hauser of the Minneapolis Heart
Institute says he contacted Medtronic in
early February about the problem and published
a review of the injury cases in late March.
Indeed, The Heart Institute was so concerned
about the risk that it ceased implantation
of these defibrillators in January. (Conversation
with Dr. Robert Hauser, October 16, 2007.)
2. As of January, Medtronic and the FDA
already were aware of an escalating number
of reports of injury in patients with this
Fidelis lead. By Jan. 10, the cumulative
number of injury reports associated with
this lead reported to the FDA database was
599, including 204 cases in which patients
got inappropriate electric shocks from their
defective defibrillators. (See table below.)
Despite this strong warning signal about
these defective components, in the same month,
January, Medtronic launched a massive direct-to-consumer
advertising campaign to lure patients to
seek advice from their doctors as to whether
they could benefit from having a defibrillator
implanted.
The $100 million Medtronic ad campaign,
dubbed "What’s Inside," including
a commercial in which a soft voice promises
viewers that inside the device, they’ll
find "10,000 more kisses ... 200 more
football wins," saying it will "always
be there for you -- close to your heart
with the power to restart it in case of sudden
cardiac arrest." The ad was clearly
trying to frighten people, including many
who would not be candidates for such devices.
The goal? Turn that fear into a "let’s
not take a chance" mentality that results
in more consumers, inadequately informed
by the ad, asking their doctors for the devices.
Why did the FDA, aware of the rising toll
of injuries from Medtronic defibrillators,
not stop this advertising campaign?
In summary, the congratulatory comments
by both the FDA and Medtronic have covered
up the serious problems of the failure of
an earlier recall and the FDA's failure
to stop Medtronic's outrageous and
irresponsible Medtronic direct-to-consumer
ad campaign.
We look forward to a prompt response to
these serious problems.
Sincerely,
Sidney M. Wolfe, MD
Director
Eunice Yu, Staff Researcher
Health Research Group of Public Citizen
